Rapid Endoscopic Gastrointestinal Irrigation System for Gastrointestinal Bleeding

ABSTRACT

The present invention relates to surgical instruments used in combination with endoscopes during gastrointestinal procedures for clearing a surgical site of unwanted obstructions, such as blood and/or clots. More particularly, the irrigation devices according to the invention comprise a handle comprising valves for controlling fluid flow, at least one channel for transporting fluid, and a connection port adapted to communicate directly or indirectly with an endoscope for delivering fluid to and receiving fluid from and through the endoscope. The irrigation devices and systems incorporating them can be used in any endoscopic gastrointestinal surgical procedure to clean, clear, or evacuate an area of the gastrointestinal tract, such as the stomach, in cases of accidental poisoning, drug overdose, or gastrointestinal bleeding. The irrigation device according to the present invention is capable of clearing a stomach within seconds or up to 1-2 minutes.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a U.S. National Stage application of InternationalPatent Application No. PCT/US07/77393, filed on Aug. 31, 2007, which hasbeen published as International Publication No. WO2009/029106 on Mar. 5,2009, the disclosure of which is incorporated by reference herein in itsentirety.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates generally to the field of medical devices.More particularly, the present invention relates to surgical instrumentsthat can be used in endoscopic procedures, such as endoscopicgastrointestinal surgery, for clearing a surgical site of unwantedobstructions, such as blood and/or clots.

2. Description of Related Art

Current methods for cleaning, clearing, or stopping bleeding duringendoscopic gastrointestinal procedures typically involve manuallyirrigating the surgical site with saline, then aspirating the saline andother debris manually away from the site. Current manual evacuationmethods include injecting a saline solution into the patient at thesurgical site using a syringe in combination with tubing, thenevacuating the fluid by reversing the movement of the plunger of thesyringe. One such system is the Kimberly-Clark Easi-Lav gastric lavagesystem. The disadvantages to this system, however, include only beingable to deliver then aspirate small amounts of saline and debris. Usingsuch manual evacuation techniques, the irrigation/evacuation steps mustbe performed numerous times successively to clear the site adequately,which can take on the order of up to a half hour or more to evacuate alarge area, for example, the stomach.

Complicating matters, such evacuation systems are typically used with aseparate scope system to determine whether the surgical site has beenadequately cleared. For upper gastrointestinal procedures, the separatescope, which is typically housed within a thin flexible tube, is usuallyinserted, removed, and reinserted through the patient's throat aftereach cleaning or evacuation step. This process of irrigating/evacuatingthen checking with a scope must be repeated until the surgeon issatisfied with the clearing overall. Numerous disadvantages exist withsuch techniques, including to name a few: 1) an increased risk ofpatient infection and/or discomfort by the constant insertion into andremoval from the patient of various instruments during surgery; (2)increased surgical time; (3) the patient is under the influence ofanesthesia for prolonged periods; and (4) an increase in costs forlonger, complicated, more involved surgery.

Because of the lack of adequate surgical instruments for endoscopiccleaning, clearing, or stopping an active bleed at a surgical site,surgeons have been known to improvise by modifying instruments typicallyused for other purposes. Improvising during surgery, however, is oftentime consuming for the surgeon, which is not desirable especially in anemergency situation. Tools and instruments at the surgeon's disposalalso are typically not adaptable to fit the surgical situationprecisely. In addition, because the instruments available to the surgeonare made for different purposes and are not configured to cooperate witheach other, the surgeon is still faced with the predicament ofintroducing, removing, and reintroducing different instruments into andout of the patient during surgery.

Thus, there exists a need for a streamlined approach for performingefficient endoscopic clearing of a gastrointestinal surgical site ofunwanted matter and/or stopping or controlling an active bleed. Inparticular, there exists a need for an automated endoscopic surgicalinstrument capable of quickly irrigating and evacuating agastrointestinal cavity of a patient, for example, to control or stopgastrointestinal bleeding.

SUMMARY OF THE INVENTION

The devices and systems of the present invention are suitable for useduring any endoscopic procedure, such as endoscopic gastrointestinalprocedures. For example, during an upper gastrointestinal procedure theirrigation system according to the invention can be used to clear asurgical site of unwanted matter, such as blood or clots, which may beinterfering with performance of the surgery. The system according to theinvention can also be used to identify a source of bleeding and tocontrol the bleeding so that a surgical procedure can be performedand/or the cause of the bleed can be repaired.

The present invention includes devices, systems, and methods forendoscopic clearing of a surgical site of unwanted matter. The presentinvention can be used in any surgical procedure, for example,gastrointestinal irrigation, to clean, clear, or evacuate an area, suchas the stomach, in cases of accidental poisoning, drug overdose, orgastrointestinal bleeding. Depending on the severity of the evacuationneeded, the devices according to the invention are capable of clearing astomach sufficiently within seconds or up to 1-2 minutes. This issubstantially faster than existing techniques, which can take up to ahalf hour or longer. For example, the device according to the inventioncan clear one unit of blood in about 5 min. Such efficiencies lead tobetter results for the patient, which typically equates to less time insurgery, faster injury repair, and/or less blood loss by the patient. Incases of gastrointestinal tract bleeding, for example, the presentinvention can be used to identify and control the bleeding quickly toenable the surgeon to repair the injury faster, which in some cases maytranslate to a total blood loss difference in the patient on the orderof 1-4 units of blood. The present invention, thus, provides devices,systems, and methods for endoscopic visualization, control, or repair ofan active bleeding site within the body, such as the gastrointestinaltract, in a fraction of the time that current methods provide.

Included within the scope of the present invention is an irrigationdevice for endoscopic surgery comprising a handle having valves forcontrolling fluid flow; at least one channel for transporting fluid; anda connection port adapted to communicate with an endoscope fordelivering fluid to and through and receiving fluid from the endoscope.The irrigation devices can be used for gastrointestinal procedures. Theirrigation device can be configured to cooperate with any endoscope.Examples of endoscopes include gastroscopes, colonoscopes,sigmoidoscopes, and enteroscopes to name a few. The irrigation device istypically compatible with endoscopes that are intended for use through anatural or existing orifice of a patient's body, however, the irrigationdevice can also be configured to be compatible with a laparoscope, whichis intended to be used through a surgical incision introduced to apatient's body. Further, the endoscopes can be diagnostic or therapeuticin nature, meaning the endoscopes can be used to examine and diagnose apatient and/or to treat a patient, such as by performing a biopsy orcauterization.

In embodiments, the irrigation devices according to the invention cancomprise at least three channels, each for transporting fluid from afluid source to the irrigation device or for transporting fluid to awaste container from the irrigation device. For example, the irrigationdevices can comprise a first channel capable of transporting irrigationfluid to the irrigation device, a second channel capable of transportingpressurized gas to the irrigation device, and a third channel capable oftransporting aspirated fluid from the irrigation device.

The irrigation devices are capable of transporting any irrigation fluidor wash fluid, including saline and water, and any pressurized gas,including air and carbon dioxide or combinations thereof.

The irrigation devices according to the invention can be incorporatedinto systems for endoscopic gastrointestinal surgery and/orgastrointestinal irrigation systems, as well as included in methods ofgastrointestinal surgery, methods of gastrointestinal irrigation, andmethods of providing instruments for endoscopic procedures.

Systems for endoscopic surgery are also included in the invention. Suchsystems comprise: 1) an irrigation device comprising a handle comprisingvalves for controlling fluid flow, at least one channel for transportingfluid, and a connection port adapted to communicate with an endoscopefor delivering fluid to and through and receiving fluid from theendoscope; 2) an endoscope; and 3) a supply of fluid and suction. Suchsystems can be used for endoscopic gastrointestinal procedures. Inembodiments, the connection port of the irrigation device may be adaptedto communicate either directly or indirectly with the endoscope. Forexample, a connector, fitting, or other adapter (including anycombination of tubing, connectors, fittings, and adapters) could be usedto join the irrigation device to the endoscope. The structure forconnecting the irrigation device to the endoscope need not conform toany particular configuration. For example, the intermediate structuremay comprise a Y-shaped adapter, wherein one channel of the Y-shapedstructure is used for the passage of fluids to and from the irrigationdevice and the other channel is used to introduce auxiliary therapeuticinstruments into the patient through the endoscope, such as biopsyforceps or an instrument for cauterization.

Surgical systems in accordance with the invention preferably comprise aportable source of fluid and a portable storage for waste disposal. Forexample, in embodiments, the systems according to the invention cancomprise a portable base unit which houses the fluid source(s) and wastereceptacles and which can comprise power source(s).

Included within the invention are systems for endoscopic irrigation,such as gastrointestinal irrigation, comprising: 1) an irrigation devicecomprising a handle comprising valves for controlling fluid flow, atleast one channel for transporting fluid, and a connection port adaptedto communicate directly or indirectly with an endoscope for deliveringfluid to and through and receiving fluid from the endoscope, and 2) asupply of fluid and suction. Such irrigation systems are capable oftransporting irrigation fluid (e.g., saline or water), pressurized gas(e.g., carbon dioxide or air), and suction (e.g., vacuum). Theirrigation systems can further comprise a Y-shaped adapter forconnecting the irrigation device to the endoscope for therapeuticpurposes. The term “adapter” as used in the context of this applicationis meant to encompass any intermediate structure, or combinations ofstructures, that is used between the irrigation device and thecooperating endoscope. Means for connecting the intermediate structureto either or both of the irrigation device and the endoscope may beincorporated into any or all of the intermediate structure, theirrigation device, and/or the endoscope.

The irrigation devices, surgical systems, and methods comprising themcan further comprise a pressure sensor for monitoring fluid pressure.

Portable irrigation systems, including portable fluid supplies, wastereceptacles, and power source(s), such as a battery, are also includedwithin the invention.

Methods of providing instruments for endoscopic irrigation or endoscopicsurgery, including gastrointestinal irrigation and/or endoscopicgastrointestinal surgery, are also encompassed by the invention. Forexample, methods of providing instruments, such as an irrigation deviceand/or irrigation system according to the invention, to surgeons, othermedical practitioners, or institutions for performing endoscopic patientprocedures form a part of this invention. More particularly, theinvention includes performing surgery with, supplying, or providingirrigation devices and systems of the invention for medical procedures.Supplying or providing the devices and systems encompasses making thedevices and systems available for use in endoscopic procedures.

The rapid endoscopic irrigation devices and systems according to theinvention are designed to be compatible with and can compriseconventional endoscopes, for example, endoscopes used ingastrointestinal surgery. In one embodiment, the irrigation device isconfigured to be a component of an endoscope and is designed to be heldand operated by the surgeon in one hand, while the cooperating endoscopeis concurrently held and operated by the surgeon in the other hand. Theirrigation device can be connected directly to the endoscope or can beindirectly connected by way of a tubing adapter having one or morechannels, such as a Y-shaped adapter. In embodiments, multiple adapterscan be provided in a kit, so as to provide multiple options for thesurgeon, such as to provide the option of introducing auxiliaryinstruments into the patient through the endoscope. In embodiments, kitsand adapters preferably comprise, or are configured to cooperate with,quick-connect/disconnect fittings for communication with the port of theirrigation device as well as with the ports of various endoscopes. Kitsand adapters can comprise, for example, multiple fittings to present thesurgeon with various options for using multiple types of endoscopes. Insuch kits, the fittings can be incorporated into the intermediatestructure (adapter), can be incorporated into the irrigation devicesand/or endoscopes, or can be separate structure.

Several systems are provided by the present invention. In one system,there is an endoscope, an irrigation system, and a base supply unit. Thesupply unit, which can be portable, provides for electricity forpowering the complete system as well as reservoirs for the fluidsupplies, such as saline, water, carbon dioxide, and air, and means forsuction.

The irrigation devices according to the present invention generallycomprise a means for holding the irrigation device (such as a handle),means for controlling fluid flow (such as valves, e.g., push-buttonvalves), and one or more means for transporting fluids (such as fluidchannels). The fluids are transported through the irrigation deviceunder pressure and means for controlling fluid flow, such as valves or avalve system, is incorporated into the device.

In the context of this invention, fluid is any matter that has atendency to flow, e.g., matter comprising molecules that move freelypast one another. Fluid includes any gas or liquid, including water,saline, air, and carbon dioxide to name a few.

The fluid channels of the irrigation devices are comprised of tubing,which lead from a fluid source or a fluid reservoir to the irrigationdevice. In one embodiment, three fluid channels or tubes lead from eachof an irrigation fluid source, a pressurized gas source, and a wastereservoir.

The tubing of the irrigation devices is connected to the fluid sourcesand the waste receptacle (preferably housed on or in a base supply unit)by any means, such as a quick-connect/disconnect means, which allows foreasy and efficient set up of the irrigation device with the fluid supplyand waste containers. More particularly, one tube is connected to apressurized gas source (such as carbon dioxide or air), a second tube isconnected to a saline or water source, and a third tube is connected toa waste receptacle. In embodiments, the three separate tubing channelscan be incorporated into a multi-tube connector, which can cooperatewith a complimentary multi-tube connector at the connection of theirrigation device with the base supply unit. At or within the irrigationdevice or at some point between the fluid supply or waste receptacle andthe irrigation device, the separate tubing can continue through thedevice as three individual passageways, or can be converged into asingle fluid passageway, which leads to a cooperating endoscope.

The fluid passageway(s) within the irrigation device lead to an exitport of the irrigation device, which is connected directly or indirectlyto a conventional endoscope. Regardless of the number of passagewaysleading from the irrigation device to the endoscope, the endoscope mayhave one or more channels for transporting fluids. For example, if threechannels exit the irrigation device, the channels can converge into asingle channel of the endoscope or can continue as three or fewerseparate channels of the endoscope. The irrigation device can beconnected to the endoscope by an adapter. Typically, such an adapter cancomprise tubing and can for example be Y-shaped to allow for theintroduction of auxiliary instruments during surgery through a secondchannel.

The irrigation devices according to the invention can be configured tobe compatible with any conventional endoscope, including anygastroscope, colonoscope, sigmoidoscope, or enteroscope, to name a few.For example, the irrigation devices can be used with gastroscopesmanufactured by Olympus under the GIF-series, including the OlympusGIF-100, GIF-1T100, GIF-1T140, GIF-2T100, and GIF-XTQ160; andgastroscopes manufactured by Pentax under the EG- or FG-series,including Pentax EG-1540, EG-3800T, EG-2930K, or FG-24X to name a few.The irrigation devices can be used with colonoscopes, including OlympusCF- or PCF-series colonoscopes, for example, Olympus CF-100L, 100-TL,140L, 1T100L, or 20L, and including Pentax EC-series colonoscopes, forexample, Pentax EC-3400F, 3400L, 3430L, 3801L, and 3872LK to name a few.Further, the irrigation devices can be compatible with sigmoidoscopes,including any of the Olympus CF-, P-, OSF-, or FS-series, including forexample Olympus CF-100S, CF-140S, P10S, OSF, OSF-2, OSF-3, FS-34P, orFS-34P2. Enteroscopes that the irrigation devices can be compatible withinclude the Olympus SIF-100 enteroscope.

Means for connecting the exit port of the irrigation device to theendoscope can comprise any known connecting means, especially meanshaving a quick-connect/disconnect feature. Connecting means forattaching the irrigation device to the endoscope is preferablyconfigured so as to communicate with and establish a leak-resistant sealwith the auxiliary tool port of the endoscope to allow for the deliveryand aspiration of fluids such as saline, water, carbon dioxide, air, andother fluids and matter through the endoscope into and out of thepatient. The connecting means need not require a direct connectionbetween the irrigation device and the endoscope. For example, thecomponents of the system may be connected by an intermediate structure(adapter), which comprises any combination of tubing and/or connectors.The adapter can comprise quick connect/disconnect features at theconnecting ends so as to facilitate connection with the irrigationdevice at one end and the endoscope at the other. Further, the adaptercan comprise one or more additional ports or channels for therapeuticinstruments to be used in conjunction with the system, such as aY-shaped adapter, including asymmetric Y-shaped adapters.

In embodiments, the fluids are supplied to the irrigation device underpressure. The irrigation fluid source can be a saline drip in whichgravity is used to deliver the saline into the patient. If more fluidpressure is desired, however, a pump can be included with the system todeliver the saline from the saline source. A pump can be used alone orin combination with a saline drip or the two can be used concurrently oralternatively. The saline is typically delivered in relatively largevolumes at a low velocity but can also be delivered in low volumes at ahigh velocity, depending on the pressure supply. Different surgicalcircumstances may call for different fluid functions, such as using ahigh volume of saline to wash out matter from a patient or dilute matterwithin the patient, whereas low volumes in relatively high velocitystreams can be used to break up larger material and debris or focus thesaline stream in a certain place.

In embodiments, saline or other washing fluid such as water can besupplied under pump pressure. Preferably, an electric-driven pump witheither portable or fixed electricity is used to deliver saline throughthe irrigation device and system. Any conventional pump capable ofproviding appropriate fluid pressure can be used. The pump canadditionally comprise a regulator for controlling the maximum fluidpressure for the system.

The irrigation devices and systems according to the invention providefor the delivery of pressurized gas, for example, carbon dioxide or air,in cases where it is desired to insufflate a cavity within the patient.Such insufflation functionality can be beneficial in situations wherethe surgeon desires to move folded tissue out of the way, which may beobstructing the surgical site or which may itself constitute thebleeding or surgical site. Pressurized gas such as air or carbondioxide, can be delivered to the patient to temporarily insufflate thecavity. As with the delivery of wash fluid into the patient, the sourceof gas is also provided under pressure. A pump, however, is typicallynot required to deliver the gas source, as the gas is typically storedand contained within a pressurized housing. Thus, the gas isautomatically delivered under pressure when released from the container.To be sure that an appropriate amount of pressure and/or gas isdelivered, a regulator may be used in conjunction with delivering thepressurized gas source through the irrigation device and system.Although air can be used to insufflate a cavity within the patient,carbon dioxide may be preferred in some circumstances because it is morereadily absorbed by the body through the gastrointestinal tract.

If a pump is used for aspirating or suctioning fluid and debris from apatient, any conventional pump known in the art can be used. Forexample, the pump can be provided as an in-wall vacuum system astypically supplied by a hospital or an electric-driven pump having asource of power such as a battery and/or means for connecting the pumpto an electrical supply. In embodiments, the same pump used forintroducing fluids into the patient can be used for removing fluids anddebris from the patient.

The irrigation device is controllable by, preferably, a hand-held devicewith controls for directing the flow and/or aspiration of fluids. Forexample, the hand-held portion can be ergonomically shaped. It can becomprised of plastic or metal. The hand-held device comprises keys(e.g., push buttons), mechanical means for controlling fluid flowthrough the irrigation system, e.g., valves for stopping fluid flow byobstructing the tubing channels with some structure and for startingfluid flow by moving the obstruction out of the fluid path. Fluid iscaused to move through the channels by way of, for example, pumps. Inone embodiment, a pump can be used to cause the saline from the salinesource to be imported into and through the irrigation device.Alternatively, or concurrently, the saline can be moved through thesystem by using a bag or other container to hold the saline at a height(for example, above the patient) that would allow for gravity to imposea pressure on the fluid, thus, moving it through the tubing.

The mechanical buttons for controlling fluid flow preferably operateindependently of one another and can be operated simultaneously orindividually. For example, carbon dioxide and saline can besimultaneously or consecutively introduced to the patient through thisdevice. Likewise, matter (carbon dioxide, air, saline, blood, debris,etc.) can be removed from the patient by aspiration before, after, oreven during introduction of additional fluids into the patient.

In embodiments, one or more pressure sensors can be incorporated intothe device or system to monitor and/or control pressure within thepatient's body. Too much fluid introduced into the patient canpotentially cause injury/damage to the patient. As an example, if asurgeon were operating the device to clear a patient's stomach, theremay be a certain pressure the patient's stomach would tolerate frompressure caused by the introduction of fluid into the patient's body.Pressure monitors could be used to deliver a warning to the surgeon thatinternal pressure of the patient is at a dangerous level and/or be usedto automatically shut down the system when pressure is at a criticallevel.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings, which are incorporated in and constitute apart of this specification, illustrate several embodiments of theinvention. Together with the written description, these representativeembodiments serve to explain certain principles or details of variousaspects of the present invention.

FIG. 1 shows a representative irrigation device.

FIGS. 2A, 2B, 2C, and 2D show various views of a representativeirrigation device.

FIG. 3 shows a base supply unit for a representative irrigation system.

FIG. 4 shows a representative conventional endoscope.

FIG. 5 shows a detailed view of a port for a conventional endoscope.

FIG. 6 shows a detailed view of the insertion tube of a conventionalendoscope.

FIGS. 7A, 7B, 7C, and 7D show representative structure for means forconnecting the irrigation device to the base supply unit and/or theendoscope by way of a quick-connect/disconnect feature.

FIG. 8 shows representative intermediate structure for connecting theirrigation device to the endoscope, e.g., a Y-shaped adapter.

DETAILED DESCRIPTION OF VARIOUS EMBODIMENTS OF THE INVENTION

Reference will now be made in detail to various exemplary embodiments ofthe invention, examples of which may also be illustrated in theaccompanying drawings. The following detailed description is provided togive the reader a better understanding of certain features and detailsof embodiments of the invention, and is not to be understood as alimitation on any aspect or feature of the invention as broadlydisclosed herein, depicted in the figures, or claimed. It will bereadily apparent to those of skill in the art that various othermodifications to the present invention may be made without departingfrom the scope and spirit of the invention.

FIG. 1 shows a representative irrigation device (100) according to theinvention. As used in the context of this application the term“irrigation device” is used to refer to any auxiliary surgicalinstrument with multi-function capabilities, including suction,irrigation, and insufflation functions, for use concurrently with anendoscope. For convenience, such auxiliary devices according to theinvention may be referred to in this application simply by any one ormore of the multi-function capabilities. For example, the auxiliarydevices may be referred to simply as irrigation devices, even though theirrigation devices have other capabilities in addition to the irrigationfunctionality.

As shown, irrigation device (100) is a hand-held device for useconcurrently with an endoscope. Conventional endoscopes typicallycomprise a port for the connection and interaction with other componentinstruments. The irrigation device is configured to connect indirectlyor directly, conveniently, and quickly to the component instrument portof a corresponding endoscope by way of a quick-connect mechanismincorporated into exit port (101) of the irrigation device. Any standardconnecting mechanism will suffice. Connections that provide for ease ofuse, a leak-resistant, preferably leak-proof, seal between the endoscopeand the irrigation device, and which have rapid connect/disconnectcapabilities are preferred. Any male/female fitting, e.g., such as ascrew and counter-screw combination, barbed, flare, compression,push-to-connect, and cam fittings to name a few, will suffice. Theirrigation device may be connected indirectly to the endoscope, forexample, by way of intermediate structure. In embodiments, the means forconnecting the intermediate structure to the endoscope and irrigationdevice can comprise tubing having connectors at either end to connect tothe device and endoscope, or the means for connecting can beincorporated into the endoscope and/or the irrigations device, or can bestand alone.

The irrigation device is controlled by a surgeon in one hand, while theconnected endoscope is operated and controlled by the surgeon in theother hand. An advantage to connecting the irrigation device directly tothe endoscope is that all functions of the surgery can be performedthrough one tube that is inserted into the patient, namely the insertiontube of the endoscope. Thus, there is no need for multiple tubes to beinserted into the patient and the surgeon is not required to insert,remove, and reinsert the instruments used during surgery because allinstrument functions are operated by the surgeon through the insertiontube of the endoscope. The single tube extending from the endoscopepreferably comprises one or more channels for delivering and aspiratingfluid and for supplying a camera for viewing.

The hand-held irrigation device can be configured to have one or morechannels (102) for transporting fluids into or out of the patient. Fluidchannels (102) can be further comprised in a sheath (103), i.e., housingfor containing and controlling the multiple channels. Sheath (103) isthen connected or contained within housing (104) of the irrigationdevice. One of channels (102) can be used for delivering saline into agastrointestinal cavity of a patient, such as the stomach. A secondchannel (102) may be used for aspirating or evacuating fluids and othermatter from the patient, including blood and clots, or saline and gasintroduced into the patient. A third fluid channel (102) may be used todeliver pressurized gas, such as air or carbon dioxide, into the patientto insufflate the patient's internal cavity for improved viewing at thesurgical site. Additionally, a single channel may be dedicated to asingle fluid or may be used to transport more than one fluid or performmore than one fluid function, such as transporting saline and aspiratingfluids.

Fluid flow within channels (102) is controlled by the surgeon preferablyby way of finger-tip controls. In this embodiment, three push-buttoncontrols (106) provide means for controlling fluid through fluidchannels (102). Controls (106) can comprise any type of valve and valvecontrol system for allowing fluids to flow in or out of the hand-helddevice.

Depending on the number of channels in the cooperating endoscope, fluidchannels (102) of the hand-held device can converge at controls (106)into one or more corresponding transition channels (105). Transitionchannels (105) lead from the irrigation device to the cooperatingendoscope. Although, e.g., three channels (102) may be used todeliver/remove fluids into/out of the irrigation device from/to thefluid supply/waste storage, one transition channel (105) could be usedto transport any of the multiple fluids to and from the patient througha single corresponding channel of the endoscope. Any conventionaladapter or intermediate structure may be used to converge multiplechannels (102) into transition channels (105) either within housing(104) or prior to the tubing entering housing (104). Further, channels(102) at the point of the valve system within housing (104) may emptyinto a single chamber, which then leads to one or more transitionchannels (105) out of irrigation device (100) and into a cooperatingendoscope.

Advantages, however, may be achieved by having dedicated channels inboth the device and the endoscope for particular fluids and/orfunctions, for example to be able to aspirate fluid from the patientwhile concurrently introducing saline into the patient for continuouscleaning of the surgical site. A single transition channel (105),however, also has advantages in that the corresponding endoscope can beless complex by having only one channel for fluid functions. Regardlessof the number of channels entering and exiting the irrigation device,the irrigation device can easily be configured by one of ordinary skillin the art to achieve the appropriate goal by configuring appropriateconnectors and/or adapters both within the irrigation device and withrespect to the quick connect function of exit port (101).

The hand-held irrigation device can be configured so as to becomfortable and convenient for the surgeon to hold. For example, thedevice can comprise a pistol-type grip with structure for providingadditional security for handling the device during surgery, for exampleby providing rubber or other grip-enhancing material to contact thesurgeon's palm or fingers on the grip. The hand-held device is alsopreferably weight balanced so as to minimize the effort required by thesurgeon's grip in holding and operating the device. The device can alsocomprise structure for resting the device in the surgeon's hand, such asthumb rest (107), which can be used to support the instrument during useof the irrigation device between the surgeon's thumb and forefinger.

FIGS. 2A, 2B, 2C, and 2D show various views of irrigation device (200).In particular, FIG. 2A shows a top view of irrigation device (200)comprising optional support structure (207), which provides means forcontrolling positioning and operation of the device during surgery.Support structure (207) may also be referred to as a thumb rest, whichcan be cradled by the surgeon's hand between the thumb and forefinger.Thumb rest (207) provides stability and enhances control of the deviceduring use. Also shown is exit port (201), which provides means forconnecting the irrigation device to an endoscope. Exit port (201) can beconnected directly to an endoscope by comprising structure for suchdirect connection or can be connected to the endoscope indirectly bycooperating with intermediate structure, such as adapters (which cancomprise any combination of tubing, fittings, or connectors).

FIG. 2B shows a profile view of irrigation device (200). Irrigationdevice (200), as shown, can conform to a generally pistol-type grip butcan also conform to any shape convenient and comfortable for a surgeonto use. The instrument will preferably comprise an ergonomically-shapeddevice that is substantially rigid, for example comprised of hardplastic or metal. As shown, the overall shape of the device housing cancomprise approximately a right angle. The housing may also be configuredto comprise an overall shape of greater than or less than a right angleand additional advantages may be achieved under certain circumstanceswith such configurations. For example, a housing comprising greater thana right angle may contribute to unimpeded fluid flow through the tubingcontained within the housing due to having less of a bend in the tubingwithin the housing. A close-up view of exit port (201) is provided toshow that exit port (201), which connects indirectly or directly with anendoscope, can form part of the housing of the device and can, forexample, connect to the endoscope by being inserted into the auxiliaryinstrument port of the endoscope or the auxiliary instrument port can beinserted into port (201) of the irrigation device. Port (201) may alsoconnect to the endoscope by way of intermediate structure, for example,structure substantially comprising tubing having means for communicatingwith exit port (201) and a cooperating endoscope. In this embodiment,exit port (201) of the irrigation device is configured with aquick-connect/disconnect fitting to provide for connection with theendoscope or intermediate structure. The connection feature incorporatedinto the irrigation device can be of any configuration (e.g., male orfemale) so long as the endoscope and/or intermediate structure comprisestructure for cooperating with the connecting feature of the irrigationdevice. Examples of such connecting means can be found in FIGS. 7 and 8.Means for connecting the irrigation device and/or the intermediatestructure to the endoscope can be incorporated into any of thecomponents of the system or can be stand alone.

A close-up view of sheath (203) comprising tubing channels (202) isfurther provided by FIG. 2B. Sheath (203) is optional for containing andcontrolling tubing channels (202), which lead from the fluid and suctionsupplies to the hand-held irrigation device. Sheath (203) can compriseany flexible material, such as fabric, rubber, plastic, or metal mesh toname a few. Tubing channels (202) lead individually from the fluid andsuction supplies to the irrigation device (200), however, the number oftubing channels (202) can be reduced from three to one, if desired, atany point in the system, including at the fluid or suction supply, atthe irrigation device, and/or at the endoscope. For example, within theirrigation device at the valves, tubing channels (202) can converge intoone chamber/channel. A single channel passing through irrigation device(200) may be advantageous in reducing the complexity of irrigationdevice (200), which can cooperate with similarly less complexendoscopes, e.g., endoscopes with only one fluid channel.

FIG. 2C shows representative means for controlling fluid flow throughirrigation device (200). As shown, such means can be provided by pushbuttons (206), which when depressed will permit flow of one or more ofthe suction, carbon dioxide, and/or saline functions. Likewise, whenreleased, push buttons (206) will suspend fluid flow. Buttons or keys(206) are preferably mechanical in nature and can comprise a valvesystem for controlling fluid flow through the device. Additionally,buttons (206) preferably operate individually and/or cooperatively toprovide one or more functions concurrently.

FIG. 2D shows a representative irrigation device (200) havingflexibility in sheath (203), which contains the tubing fortransportation of fluids from the fluid supply to the endoscope and fromthe endoscope to waste.

FIG. 3 shows a representative base unit (300), which can be combinedwith the irrigation device and an endoscope to comprise an endoscopicirrigation system according to the present invention. Base unit (300),as shown, is preferably portable. Base unit (300) can comprise powersource(s) (301), such as a battery, or can be configured to plug into aseparate electrical source, such as a wall outlet. Additionally, anycomponent of base unit (300), which requires electricity, can compriseits own source of electricity. For example, the pump(s) for providingirrigation fluid and/or the suction source may comprise their own sourceof power, such as by incorporating a portable suction unit into baseunit (300). Portability of base unit (300) can be further enhanced byhaving base unit (300) comprise its own source(s) of power.

Base unit (300) further comprises an irrigation fluid supply (302).Fluid supply (302) can comprise a container or reservoir for storingliquid. The container can be rigid, for example made of hard plastic, orthe container can be flexible, for example comprising a bag or otherreservoir typically used for storing saline or water, such as containersfor saline drip. Exporting the irrigation fluid from fluid supply (302)to the irrigation device can be achieved by having tubing reach thebottom of the container or by having an exit port at the bottom of thecontainer, which communicates with tubing extending to the irrigationdevice. Fluid supply (302) is preferably incorporated into base unit(300), however, base unit (300) can also be configured to connect withan external source of irrigation fluid. Again, portability of base unit(300) may be enhanced by incorporation of a fluid source (302) into baseunit (300).

A pump (303) is preferably included with base unit (300) to providemeans for delivering the irrigation fluid from fluid supply (302)through the device and endoscope to the patient. Any pump fortransporting fluids may be used. The pump (303) may be used alone or incombination with other means for moving fluids, such as by way of salinedrip. A saline drip may provide sufficient fluid pressure under certaincircumstances, e.g., if only low pressure fluid is needed. A pump (303),however, may be advantageous in certain circumstances for providingblasts of wash fluid to break up large clots or to clean the surgicalsite rapidly. In embodiments, pump (303) and fluid supply (302) cancomprise an otherwise stand-alone pump and fluid supply that isincorporated into base unit (300) and has its own source of power.

Base unit (300) further comprises a source for pressurized gas (304). Toenhance portability, the pressurized gas supply (304) can beincorporated into base unit (300). Pressurized gas supply (304) can alsobe supplied by an external source to which base unit (300) is connectedto and cooperates with, such as a wall supply of gas typically found inhospitals. The type of gas can be any gas under pressure, such as carbondioxide or air. Pressurized gas itself provides sufficient pressure forthe surgeon without the need for a separate pump to deliver the gas. Thepressure of the gas can be controlled by any type of regulator or othervalve system, including or in addition to the valve system of thehand-held irrigation device. For example, to prevent gas from enteringthe patient at too high a pressure, one pressure regulator can be usedat the gas source (304) to set a maximum pressure, while the flowcontrol can be adjusted at the fingertip controls of the hand-helddevice, such as by having means for regulating fluid flow in addition tomeans for stopping and starting fluid flow. Having more than oneregulator for controlling fluid flow of the gas, or any of the fluidstransported by way of the invention, is preferred.

Base unit (300) additionally comprises a suction source (305) and wastereservoir (306). Suction source (305) can comprise any conventional pumpor other vacuum means. Suction source (305) can be incorporated intobase unit (300) or can be supplied from an external source, such as byway of a typical wall-embedded vacuum source found in hospital settings.Suction source (305) preferably comprises a regulator for adjusting andcontrolling fluid flow. Fluid flow can additionally be controlled bymeans for controlling fluid flow on the hand-held device. Wastereservoir (306) can comprise any container for storing waste fluid,debris, and other matter removed from the patient. More particularly,waste reservoir (306) is configured to cooperate with suction source(305) so as to receive waste aspirated through an endoscope andirrigation device by suction force supplied by suction source (305). Forexample, suction source (305) may interact with waste reservoir (306) byway of intermediate tubing entering at a first port at the top of thecontainer. A separate second port at the top of the container wouldconnect separate tubing (308) to the irrigation device. According tosuch a configuration, suction source (305) creates a vacuum in wastereservoir (306) through the first port, while fluid and debris aresuctioned from the patient through the irrigation device and cooperatingtubing into the second port of waste reservoir (306), thus, emptying thefluids and debris into the bottom of the reservoir. Fluids and debriswould avoid contact with suction source (305), so long as the fluidlevel in the container remains below the level of the first port, thesuction port. An automatic shut off feature or other warning mechanismcould be incorporated into the suction system to avoid fluids reachingthe first port and being suctioned into suction pump (305).

A pump can be used as the suction source and, in embodiments, thesuction pump and the saline pump may comprise a single pump havingmulti-channel pumping capability. Suction source (305) and wastereservoir (306) are preferably incorporated into base unit (300) forincreased system portability. One or more of the components of thesystem can be contained in, transported on, or incorporated into anystructure which enhances portability of the system, such as a cart(307).

Fluids are transported to the irrigation device from fluid source (302)and gas source (304) by way of fluid channels (308). Likewise, fluids,debris, and other wastes are transported to suction canister (306) fromthe irrigation device by way of a third fluid channel (308). Fluidchannels (308) can comprise any flexible tubing-type structure, such asplastic tubing. In this embodiment, fluid channels (308) are connectedto the irrigation device by way of a multi-tube connector (309). Thefluid channels of the irrigation device can also be connected directlyto each fluid source and/or the vacuum. A quick-connect/disconnectfitting, such as multi-tube connector (309) has advantages in certainapplications where it is desirable to be capable of assembling thesystem easily and quickly.

FIG. 4 shows a conventional endoscope (400), more particularly, agastroscope. A gastroscope is used for purposes of exemplifying theinvention, however, any endoscope may be used with the irrigationdevices of the present invention. As shown, endoscope (400) comprisesinsertion tube (401), which is the tube inserted into a patient throughthe throat to reach part of the patient's gastrointestinal tract, suchas the stomach. Insertion tube (401) comprises a camera for internalviewing of a gastrointestinal tract. Also comprised within insertiontube (401) are one or more channels for operating auxiliary tools, suchas biopsy forceps (402) and/or cauterization tools. Auxiliary tools areinserted through instrument port (403). Instrument port (403) can alsoperform other functions, such as providing suction at the surgical site.The irrigation devices of the present invention are configured tocooperate with instrument port (403) of the endoscope. The irrigationdevices of the present invention are configured to connect withinstrument port (403) by any means that provides for a leak-resistantseal. Preferably, the irrigation devices are secured to the endoscopesby a quick-connect mechanism that provides for easy and rapid connectionand disconnection of the irrigation device and endoscope. Thequick-connect/disconnect mechanism can comprise tubing with connectorson either end for joining the irrigation device with the endoscope.

FIG. 5 shows a close-up view of various portions of a typical endoscope(500). More particularly, the irrigation devices of the presentinvention are configured to cooperate with instrument port (503) of theendoscopes. For example, an irrigation device could be configured with afemale-type exit port that mates with a male-type instrument port (503)of the endoscope, or vice versa. Further, an adapter (such as anycombination of tubing channels, fittings, and connectors) could be usedto connect instrument port (503) to the irrigation device. Structure canbe incorporated into the exit port of the irrigation device and/or theinstrument port (503) of the endoscope for providing a leak-resistantseal, such as a rubber washer, O-ring, or other structure, and forproviding simple connect/disconnect, such as a quick-release connectiontypically associated with connecting a hose to a water source, orconnecting tubing to tubing, or connecting tubing to some otherstructure.

FIG. 6 shows a close-up view of an insertion tube (601) of arepresentative conventional endoscope (600). As shown, insertion tube(601) comprises channel (601 a) typically used for introducing auxiliaryinstruments into a patient, such as biopsy forceps and/or cauterizationtools. Some endoscopes comprise more than one such channel (601 a).Endoscopes comprising one channel (601 a) are typically referred to asdiagnostic endoscopes, and those comprising multiple channels aretypically referred to as therapeutic endoscopes. The irrigation devicesaccording to the invention are configured so as to deliver or removefluids from a patient through channels (601 a) of an endoscope. With onechannel (601 a) of an endoscope, a cooperating irrigation device cantransport one or multiple fluid(s) in or out of a patient throughchannel (601 a). Advantages are achieved, however, with endoscopescomprising more than one channel (601 a) so that the multiplefunctionalities of the irrigation device can be performed concurrently.For example, with at least two channels (601 a) in an endoscope, acorresponding irrigation device could concurrently deliver saline to thesurgical site, while suctioning the site, so that continuous cleaning ofthe surgical site can be performed. Likewise, if continuous insufflationis needed while cleaning, one channel (601 a) could be used to deliverpressurized gas, while another channel (601 a) concurrently is used todeliver saline and/or suction the saline from the site. The number ofchannels (601 a) of the endoscope is not critical and the correspondingirrigation device can easily be adapted for use with multiple types ofendoscopes. Also shown in FIG. 6 is scope (601 b), a camera for viewingthe surgical site within the gastrointestinal tract; light sources (601c) to assist with viewing through camera (601 b); and channels (601 d)for providing small amounts of water and suction for cleaning camera(601 b) in situations where the view through the lens is obstructed. Thewater and suction sources provided by existing endoscopes are notcapable of the rapid irrigation functions provided by the presentinvention. For example, the weak suction source in combination with thesmall diameter of channel (601 d) would be incapable of evacuating largeclots from a patient as well as incapable of evacuating agastrointestinal cavity sufficiently and quickly.

FIGS. 7A, 7B, 7C, and 7D show representative fittings for connecting theirrigation device to the endoscope and for connecting the irrigationdevice to the fluid sources and/or source of suction/waste. Provided inFIG. 7A, for example are multiple types of connectors, each having aquick-connect/disconnect feature. Many variations exist for connectingthe connectors with tubing, the irrigation device, and the endoscope,including as exemplified the screw-type (709 a), the male/female withO-ring type (709 b), the male/female barbed type (709 c), and thecompression fitting (709 d). Connectors (709) can be incorporated intoany piece of the system or can be stand alone. For example, the exitport of the irrigation device itself can be configured as half of aquick-connect/disconnect structure. Likewise, connector (709) can beused in conjunction with or incorporated into intermediate structure(adapter) for connecting the irrigation device to the endoscope, or canbe incorporated into the irrigation device and/or endoscope. FIG. 7Bshows a representative multi-tube connector, which can be used forconnecting multiple fluid channels within the system. FIG. 7C provides abarbed-type connector, which also acts as a reducer to transition fromone size fluid channel to a smaller or larger size fluid channel. FIG.7D provides another example of a quick-connect/disconnect feature, whichcomprises screw-type fittings.

FIG. 8 provides a representative Y-shaped adapter (800) for connectingthe irrigation device to the endoscope. The adapters can be of anysubstantially cylindrical shape, including a single-channel cylinder.Further, for example, as shown in FIG. 8, an asymmetric Y-shapedcylinder can also be used. An asymmetric Y-shaped adapter would comprisea first channel that is substantially linear and a second channeldiverging from the first channel. Y-shaped adapters are desirable forapplications where auxiliary instruments are to be used through theendoscope. For example, irrigation, suction, and insufflation can beprovided through one channel of the Y-shaped adapter, such as the mainsubstantially linear channel, while auxiliary instruments, such asbiopsy forceps and/or cauterization instruments can be used through theother channel. Intermediate structure, adapters (800), can be configuredto have any means for connecting the adapter to the irrigation deviceand the endoscope. In embodiments, kits are provided comprising multipleadapters and/or multiple fittings. As shown in this embodiment, one endof the main channel of the adapter (800) can comprise aquick-connect/disconnect feature for connecting with a cooperatingfeature of the irrigation device and the other end of the main channelcan comprise similar structure for cooperation with an endoscope. Otherintermediate structure can be used between the endoscope and theY-shaped adapter, for example, to increase the distance between theendoscope and the auxiliary tools so that operation of the auxiliarytools is not impeded by the endoscope because of limited working space.Also, as shown, the auxiliary channel can comprise a port foraccommodating auxiliary instruments, such as biopsy forceps, which isfurther equipped with means for preventing fluids from exiting thatport, such as a rubber port that cooperates snugly with the auxiliaryinstruments to allow the instruments to be introduced to the channel,while preventing fluids from exiting that channel. A cap or other meansfor preventing fluid from exiting the auxiliary port when not in use canalso be incorporated.

It will be apparent to those skilled in the art that variousmodifications and variations can be made in the practice of the presentinvention without departing from the scope or spirit of the invention.Other embodiments of the invention will be apparent to those skilled inthe art from consideration of the specification and practice of theinvention. It is intended that the specification and examples beconsidered as exemplary only, with a true scope and spirit of theinvention being indicated by the following claims.

1. An irrigation device for endoscopic surgery comprising: a handlecomprising valves for controlling fluid flow; at least one channel fortransporting fluid; and a connection port adapted to communicate with anendoscope for delivering fluid to and receiving fluid from saidendoscope through said at least one channel.
 2. The irrigation deviceaccording to claim 1, further comprising intermediate structure forcommunicating said irrigation device connection port to said endoscope.3. The irrigation device according to claim 2, wherein said intermediatestructure comprises a Y-shaped adapter for providing instrument accessthrough said endoscope.
 4. The irrigation device according to claim 1comprising at least three channels for transporting fluid from a fluidsource or transporting fluid to a waste container.
 5. The irrigationdevice according to claim 4, wherein a first channel is capable oftransporting irrigation fluid, a second channel is capable oftransporting pressurized gas, and a third channel is capable oftransporting aspirated fluid.
 6. The irrigation device according toclaim 5, wherein said irrigation fluid is saline and said pressurizedgas is carbon dioxide.
 7. The irrigation device according to claim 1further comprising at least one pressure sensor for monitoring fluidpressure.
 8. A system for endoscopic surgery or irrigation comprising:an irrigation device comprising: a handle comprising valves forcontrolling fluid flow; at least one channel for transporting fluid; anda connection port adapted to communicate with an endoscope fordelivering fluid to and receiving fluid from said endoscope through saidchannels; and a supply of fluid and suction.
 9. The system according toclaim 8 further comprising an endoscope.
 10. The system according toclaim 9 further comprising an intermediate structure for communicatingsaid irrigation device connection port with said endoscope.
 11. Thesystem according to claim 10, wherein said intermediate structurecomprises a Y-shaped adapter for providing instrument access throughsaid endoscope.
 12. The system according to claim 8, wherein saidirrigation device is capable of transporting irrigation fluid,pressurized gas, and suction through said at least one channel fortransporting fluid.
 13. The system according to claim 12, wherein saidirrigation fluid is saline, said pressurized gas is carbon dioxide, andsaid suction is a vacuum.
 14. The system according to claim 8 furthercomprising a pressure sensor for monitoring fluid pressure.
 15. Thesystem according to claim 8, wherein said supply of fluid and suction isportable.
 16. A method of providing instruments for endoscopicirrigation or surgery comprising: providing an irrigation devicecomprising: a handle comprising valves for controlling fluid flow; atleast one channel for transporting fluid; and a connection port adaptedto communicate with an endoscope for delivering fluid to and receivingfluid from said endoscope through said channels.
 17. The methodaccording to claim 16 further comprising an intermediate structure forcommunicating said irrigation device connection port to said endoscope.18. The method according to claim 17, wherein said intermediatestructure comprises a Y-shaped adapter for providing instrument accessthrough said endoscope.
 19. A method of performing endoscopic surgery orirrigation comprising: providing an irrigation device comprising: ahandle comprising valves for controlling fluid flow; at least onechannel for transporting fluid; and a connection port adapted tocommunicate with an endoscope for delivering fluid to and receivingfluid from said endoscope through said channels; providing an endoscope;and performing an endoscopic procedure.
 20. The method according toclaim 19, wherein the irrigation device further comprises anintermediate structure for communicating said irrigation deviceconnection port to said endoscope.
 21. The method according to claim 20,wherein said intermediate structure comprises a Y-shaped adapter forproviding instrument access through said endoscope.
 22. A kit forconnecting an irrigation device according to claim 1 to an endoscopecomprising multiple intermediate structures for communicating saidirrigation device connection port to said endoscope.
 23. The kitaccording to claim 22, wherein at least one of said multiple structurescomprises a Y-shaped adapter for providing instrument access throughsaid endoscope.